Recall Class: Class I
Date Recall Initiated: June 1, 2015
Device:
- Lot numbers: Complete list of affected lot numbers:
- Manufactured from: October 2013 to April 2015
- Distributed from: October 2013 to May 2015
- Devices Recalled in the U.S.: 62,882
Product Codes: 5-15401, 5-16037, 5-16128, 5-16139, 5-16028, 5-16039, 5-16135, 5-16141, 5-16035, 5-16041, 5-16137, 5-16142
Use: An endobronchial tube is a plastic tube that is inserted through the mouth into the main passageway into the lungs (bronchi). The tube is used during a medical procedure that determines how well a lung is working (bronchospirometry).
Recalling Firm:
Teleflex Medical
2917 Weck Drive
Research Triangle Park, NC 27709
Reason for Recall: Teleflex Medical has received customer complaints about the endobroncial tube’s double swivel connector. The connector may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress. This can lead to the need to re-intubate the patient, patient injury or death.
Public Contact: Customers who have questions about this recall may contact Tara Torres-Heckman at 610-378-0131 or [email protected].
FDA District: Atlanta District Office
More Information about this Recall:
On June 1, 2015 Telefex Medical sent an Urgent Medical Device Recall Notification to their customers. In that letter they instructed customers to:
- Immediately stop using any affected products
- Quarantine affected products
- Complete the Recall Acknowledgement Form attached to the notification and fax it to 855-419-8507 (Attn: Customer Service) or email to [email protected]
- Upon completion of the form, a customer service representative will contact customers to arrange for return of the product, if necessary.
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program online, by regular mail or by FAX.
